Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation (ACA)

• ClinicalTrials.gov Identifier: NCT01398280
• Recruitment Status: Completed
• First Posted: July 20, 2011
• Results First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Tissa Hata, MD, University of California, San Diego

Tracking Information

• First Submitted Date: July 19, 2011
• First Posted Date: July 20, 2011
• Results First Submitted Date: June 4, 2019
• Results First Posted Date: September 13, 2019
• Last Update Posted Date: September 13, 2019
• Study Start Date: July 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2019)

Kallikrein 5 (KLK5) Protease Activity [ Time Frame: Up to 12 weeks ]

Serine protease activity of KLK5 in adult skin from patients with rosacea is measured after treatment with vehicle or aminocaproic acid cream. Protease activity of facial skin surface is monitored using a synthetic fluorogenic trypsin-like proteinase substrate. Protease activity is monitored as an increase of fluorescence (RFU/uL) with SpectraMax GEMINI EM.

Original Primary Outcome Measures (submitted: July 19, 2011)

Cathelicidin protein analysis [ Time Frame: Up to 12 weeks ]

To determine the effect of aminocaproic acid on the antimicrobial peptide cathelicidin in adult skin from patients with rosacea.

• Change History: Complete list of historical versions of study NCT01398280 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: July 19, 2011)

KLK5 protease activity [ Time Frame: Up to 12 weeks ]

To determine the effect of topical aminocaproic acid on serine protrease activity of kallikrein 5 in adult skin from patients with rosacea

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
• Official Title: A Single Site Evaluation of the Effect of Topical Application of Aminocaproic Acid (ACA) to Inhibit Kallikrein 5 Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation.
• Brief Summary: The purpose of this study is to determine the effect of topical aminocaproic acid on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Rosacea

Intervention

• Drug: Topical aminocaproic acid (ACA) mixed with Vanicream
  25% Aminocaproic acid cream twice daily for up to 12 weeks.
• Drug: Vehicle cream
  Vehicle cream moisturizer twice daily for up to 12 weeks

Study Arms

• Experimental: Aminocaproic Acid (ACA)
  Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity.
  Intervention: Drug: Topical aminocaproic acid (ACA) mixed with Vanicream
• Placebo Comparator: Vehicle cream
  Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity.
  Intervention: Drug: Vehicle cream

Publications *

• Yamasaki K, Di Nardo A, Bardan A, Murakami M, Ohtake T, Coda A, Dorschner RA, Bonnart C, Descargues P, Hovnanian A, Morhenn VB, Gallo RL. Increased serine protease activity and cathelicidin promotes skin inflammation in rosacea. Nat Med. 2007 Aug;13(8):975-80. Epub 2007 Aug 5.
• Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009 Aug;55(2):77-81. doi: 10.1016/j.jdermsci.2009.04.007. Epub 2009 May 29. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2013): 15
• Original Estimated Enrollment (submitted: July 19, 2011): 12
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject is male or non-pregnant female, 18 - 70 years of age.
• Subjects willing and able to give informed consent.
• Subjects willing and able to comply with the requirements of the study.
• Subject has the clinical diagnosis of at least mild/moderate papulopustular rosacea (3-20 papulopustules) and at least mild erythema.
• Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
• Subject is in general good health in the opinion of the investigator.
• Subject has a calculated creatinine clearance 100% of normal range.
• Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Exclusion Criteria:

• Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
• Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.
• Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
• Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
• Subject has had laser or light-based treatment for rosacea within the prior 3 months.
• Subject has had systemic retinoids and retinoid derivatives over the past 6 months
• Subject has an active or recent history of any coagulation (hyper or hypo) disorder, genitourinary bleeding, myopathy, cardiomyopathy, rhabdomyolysis or evidence of clinically significant hepatic disease in the opinion of the investigator,
• Subject is taking any medicines or supplements that interfere with blood clotting such as Coumadin, Plavix, or ASA (>81mg/day).
• Subject has a known hypersensitivity or allergy to aminocaproic acid or components of the vehicle.
• Subject is pregnant or lactating or planning a pregnancy during the duration of the study
• Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
• Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01398280
• Other Study ID Numbers: 100867
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tissa Hata, MD, University of California, San Diego
• Study Sponsor: University of California, San Diego
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tissa Hata, MD; University of California, San Diego

• PRS Account: University of California, San Diego
• Verification Date: August 2019